Gardasil question

[Momus]

GARDASIL is the only HPV vaccine that helps protect against 4 types of HPV.

In girls and young women ages 9 to 26, GARDASIL helps protect against 2 types of HPV that cause about 75% of cervical cancer cases, and 2 more types that cause 90% of genital warts cases.

In boys and young men ages 9 to 26, GARDASIL helps protect against 90% of genital warts cases.

-----------------------------------

Once someone hits 26, does this become off label use? If so, could a California Pharmacist immunize someone who is 1 day over 26 years old?

I know we can immunize as long as it is FDA indicated 9-26..

I was just curious about the cut off. If it is 26 year old + a couple days older, Does that mean this vaccine become off label use from that point?

---

Members don't see this ad.

 

[rph3664]

No, it just becomes much less effective. The explanation I heard is that the cervical cells mature around age 26 and if a woman hasn't acquired HPV by that time, she probably won't even if she's exposed to it.

 

[Momus]

You do not answer my question...

 

[All4MyDaughter]

No, it just becomes much less effective. The explanation I heard is that the cervical cells mature around age 26 and if a woman hasn't acquired HPV by that time, she probably won't even if she's exposed to it.

Really? So it's fine to use the day before a woman's 26th birthday, but it won't work if used the day after her 26th birthday? You can't catch HPV after age 26 (or so)? Citation?

Merck is seeking approval to market Gardasil to women between the ages of 27 and 45, so I'm not sure that what you've heard is correct. Source. This source is kind of old here is a newer one.

 

[Momus]

I got the FDA approved indication from Merck, 27-45 still not approved (thus, this is off label)...

Can a pharmacist in California do Gardisil off label immunization for someone who is 26 year old + 1 month older (between 26-27 year old)?

My question is specific, anyone knows the answer?

 

[All4MyDaughter]

Once someone hits 26, does this become off label use? If so, could a California Pharmacist immunize someone who is 1 day over 26 years old?

I know we can immunize as long as it is FDA indicated 9-26..

I was just curious about the cut off. If it is 26 year old + a couple days older, Does that mean this vaccine become off label use from that point?

No FDA indication = off label

But someone who is 1 day or 1 month past their 26th birthday is still 26... see below.

I got the FDA approved indication from Merck, 27-45 still not approved (thus, this is off label)...

Can a pharmacist in California do Gardisil off label immunization for someone who is 26 year old + 1 month older (between 26-27 year old)?

My question is specific, anyone knows the answer?

OK - I think a patient is still 26 until their 27th birthday. So you should be able to give them Gardisil until one day before their 27th birthday.

After that, I think it's off label. I don't know what California law says about pharmacists immunizing off label.

 

[Ackj]

Really? So it's fine to use the day before a woman's 26th birthday, but it won't work if used the day after her 26th birthday?

It's just like when you turn 18 you suddenly gain the knowledge to be able to vote, and the lung capacity to smoke. Then when you turn 21 you are suddenly responsible enough to buy alcohol, but not a day sooner.

 

[UBCmicrobi]

OK - I think a patient is still 26 until their 27th birthday. So you should be able to give them Gardisil until one day before their 27th birthday.

I agree with that.

In Canada, my sister can't find a doctor to give her the vaccine (she is turning 30 in a couple of months). I was able to get the vaccine via participating in a clinical trial, and I was over 26 (but before my 27th birthday). To be eligible, you had to be 26 and under (can't remember what the lower cut off was), and I qualified, despite being a few months away from my 27th bday.

Of course this doesn't answer your question, but I thought I'd share my personal experience with the age issue!

 

[Old Timer]

I got the FDA approved indication from Merck, 27-45 still not approved (thus, this is off label)...

Can a pharmacist in California do Gardisil off label immunization for someone who is 26 year old + 1 month older (between 26-27 year old)?

My question is specific, anyone knows the answer?

The answer is self explanatory. They are 26 until their 27th birthday. So therefore at this moment, anyone born after August 20, 1983 can have the vaccine in California and anyone born before that date cannot.

 

[Momus]

Cool... I guess, 26 means 27 and under, duh >_>;

$375/3 doses... I am ordering the vaccines for my self and have another staff pharmacist in my pharmacy administer it since I am still under 27 with no HPV.

I asked one of the clinical pharmacist/my immunizing trainer, they say anything off label the doc can do it but not pharmacist.. that's why I ask this question just to make sure -.-

 

[genesis09]

My insurance covers gardasil with a $0 co-pay because they consider it to be a routine vaccine. All routine vaccines are covered completely. My MD's office charges $529 per immunization. I know they must be making a good buck on it.

 

[rph3664]

When Gardasil was first released, the health department in the county adjoining mine got a grant and were able to offer it to anyone who showed up at the clinic for $5 a shot. They did not have to be residents of that county, and there were no income guidelines; they just had to be female (at the time) and between 9 and 26. I don't know if they're still offering it.

Many insurances still do not cover it because it is not mandatory.

 

[Farmercyst]

Cool... I guess, 26 means 27 and under, duh >_>;

$375/3 doses... I am ordering the vaccines for my self and have another staff pharmacist in my pharmacy administer it since I am still under 27 with no HPV.

I asked one of the clinical pharmacist/my immunizing trainer, they say anything off label the doc can do it but not pharmacist.. that's why I ask this question just to make sure -.-

Sounds like a protocol issue to me. My bet is your protocol, as signed by the supervising physician, does not allow for off-label use. If that is the case then you would be correct.

 

[aboveliquidice]

Sounds like a protocol issue to me. My bet is your protocol, as signed by the supervising physician, does not allow for off-label use. If that is the case then you would be correct.

^This... at least in Florida that is how it is determined.

Note - in Fl, we can give the flu shot - That's it...